Pramipexole Stada 0.18 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pramipexole Stada 0.18 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Pramipexole Stada is and what it is used for

2. What you need to know before taking Pramipexole Stada

3. How to take Pramipexole Stada

4. Possible side effects

5. How to store Pramipexole Stada

6. Contents of the pack and other information

1. What Pramipexol Stada is and what it is used for

Pramipexol Stada contains the active substance pramipexole and belongs to a group of medicines called dopaminergic agonists that stimulate dopamine receptors in the brain. Stimulation of dopaminergic receptors triggers nerve impulses in the brain that help control body movements.

Pramipexole is used to:

• treat the symptoms of idiopathic Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
• treat moderate to severe symptoms of idiopathic Restless Legs Syndrome in adults.

2. What you need to know before taking Pramipexol Stada

Do not take Pramipexol Stada

• If you are allergic to pramipexol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting to take Pramipexol Stada. Inform your doctor if you have or have had any illness or symptoms, especially any of the following:

• Kidney disease.
• Hallucinations (seeing, hearing, or feeling things that are not there). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson's disease and are also taking levodopa, you may experience dyskinesia during the gradual increase of pramipexol dose.
• Dystonia.
• Inability to keep the trunk and neck upright and straight (axial dystonia). Specifically, you may experience forward flexion of the head and neck (also known as antecollis), forward bending of the lumbar region (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome).
• Somnolence and sudden episodes of falling asleep.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision disorders.
• You should have regular eye examinations during treatment with pramipexol.
• Severe heart or blood vessel disease. You should have regular blood pressure monitoring, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).
• Worsening of restless legs syndrome. If you notice that symptoms begin earlier than usual at night (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or affect other limbs, your doctor may reduce your dose or discontinue treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors such as compulsive gambling, excessive eating or spending, abnormally increased sex drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may need to adjust or stop your dose.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (reduced awareness, confusion, loss of contact with reality). Your doctor may need to adjust or stop your dose.

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with pramipexol. If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Inform your doctor if you notice an inability to keep your trunk and neck upright and straight (axial dystonia). In such cases, your doctor may decide to adjust or modify your treatment.

Children and adolescents

Pramipexol is not recommended for use in children or adolescents under 18 years of age.

Taking Pramipexol Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes over-the-counter medicines, herbal remedies, natural health products, or nutritional supplements.

You should avoid using pramipexol together with antipsychotic medicines.

Use caution if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and stomach ulcers);
• amantadine (which may be used in the treatment of Parkinson's disease);
• mexiletine (used to treat irregular heartbeats, a condition known as ventricular arrhythmia);
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a disease of the human immune system);
• cisplatin (used to treat various types of cancer);
• quinine (which may be used to prevent painful leg cramps occurring at night and to treat a type of malaria known as falciparum malaria (malignant malaria));
• procainamide (used to treat irregular heartbeat).

If you are taking levodopa, a reduction in the levodopa dose is recommended when starting pramipexol treatment.

Use caution if you are taking sedative medicines (with sedative effects) or drinking alcohol. In these cases, pramipexol may affect your ability to drive or operate machinery.

Taking Pramipexol Stada with food, drinks, and alcohol

Exercise caution if you drink alcohol during treatment with pramipexol. You may take pramipexol with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will advise you whether you should continue treatment with pramipexol.

The effect of pramipexol on the fetus is unknown. Therefore, do not take pramipexol during pregnancy unless your doctor tells you to do so.

Pramipexol must not be used during breastfeeding. Pramipexol may reduce the production of breast milk and may pass into breast milk and reach your baby. If the use of pramipexol is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pramipexol may cause hallucinations (seeing, hearing, or feeling things that are not there). If this occurs, do not drive or operate machinery.

Pramipexol has been associated with somnolence and sudden episodes of falling asleep, especially in patients with Parkinson's disease. If you experience these adverse effects, you must not drive or operate machinery.

Inform your doctor if this happens.

3. How to take Pramipexole Stada

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, ask your doctor. Your doctor will determine the correct dosage for you.

Pramipexole may be taken with or without food. The tablets should be swallowed with water.

Parkinson's Disease

The daily dose should be taken in three equal doses.

During the first week, the usual dose is 1 tablet of pramipexole 0.088 mg three times daily (equivalent to 0.264 mg daily):

	Week 1
Number of tablets	1 tablet of pramipexole 0.088 mg three times daily
Total daily dose (mg)	0.264

This dose will be increased every 5-7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose).

	Week 2	Week 3
Number of tablets	1 tablet of pramipexole 0.18 mg three times a day or 2 tablets of pramipexole 0.088 mg three times a day	1 tablet of pramipexole 0.35 mg three times a day or 2 tablets of pramipexole 0.18 mg three times a day
Total daily dose (mg)	0.54	1.1

The usual maintenance dose is 1.1 mg per day. However, your dose may need to be increased further. If necessary, your doctor could increase your tablet dose to a maximum of 3.3 mg of pramipexole per day. It is also possible to reduce the maintenance dose to three pramipexole 0.088 mg tablets per day.

	Minimum maintenance dose	Maximum maintenance dose
Number of tablets	1 tablet of pramipexole 0.088 mg three times daily	1 tablet of pramipexole 1.1 mg three times daily
Total daily dose (mg)	0.264	3.3

Patients with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you should take the tablets only once or twice a day. If you have moderate renal impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg twice daily. If you have severe renal impairment, the usual starting dose is 1 tablet of pramipexole 0.088 mg once daily.

Restless legs syndrome

The dose is usually taken once daily, 2–3 hours before bedtime. During the first week, the usual dose is 1 tablet of pramipexole 0.088 mg once daily (equivalent to 0.088 mg per day):

	1st week
Number of	1 tablet of pramipexole 0.088 mg
tablets
Total daily dose (mg)	0.088

This dose will be increased every 4-7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose).

	Week 2	Week 3	Week 4
Number of tablets	1 tablet of pramipexole 0.18 mg or 2 tablets of pramipexole 0.088 mg	1 tablet of pramipexole 0.35 mg or 2 tablets of pramipexole 0.18 mg or 4 tablets of pramipexole 0.088 mg	1 tablet of pramipexole 0.35 mg and 1 tablet of pramipexole 0.18 mg or 3 tablets of pramipexole 0.18 mg or 6 tablets of pramipexole 0.088 mg
Total daily dose	0.18	0.35	0.54
(mg)

The daily dose for the treatment of restless legs syndrome must not exceed 6 tablets of pramipexole 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexole salt).

If you stop taking your tablets for a few days and wish to restart treatment, you must begin again with the smallest dose and then gradually increase the dose as you did the first time. Consult your doctor if you have any doubts.

Your doctor will evaluate your treatment after 3 months to decide whether or not to continue treatment.

Patients with kidney disease

If you have severe kidney disease, pramipexole may not be an appropriate treatment for your restless legs syndrome.

If you take more Pramipexol Stada than you should

If you accidentally take too many tablets:

• contact your doctor or the nearest hospital emergency department immediately.
• You may experience vomiting, restlessness, or any of the adverse effects described in section 4 (Possible side effects).

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone (91) 562 04 20.

If you forget to take Pramipexol Stada

Do not worry. Skip that dose completely and take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Pramipexol Stada

Do not interrupt your treatment with pramipexole without consulting your doctor. If you need to interrupt treatment with this medicine, your doctor will gradually reduce your dose. This reduces the risk of worsening symptoms.

If you have Parkinson's disease, you must not stop treatment with pramipexole abruptly.

Sudden interruption may cause a condition called neuroleptic malignant syndrome, which may pose a serious health risk. These symptoms include:

• akinesia (loss of muscle movement)

• muscle rigidity

• fever

• unstable blood pressure

• tachycardia (increased heart rate)

• confusion

• decreased level of consciousness (e.g., coma)

If you interrupt treatment or reduce the dose of pramipexole, you may also experience a medical condition called dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you should contact your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If you have Parkinson's disease, you may experience the following adverse effects:

Very common (may affect more than 1 in 10 people)

• Dyskinesia (e.g., abnormal involuntary movements of limbs)
• Somnolence
• Dizziness
• Nausea

Common (may affect up to 1 in 10 people)

• Urge to behave in an unusual way
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Tiredness (fatigue)
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbance
• Vomiting (feeling sick)
• Weight loss including loss of appetite

Uncommon (may affect up to 1 in 100 people)

• Paranoia (e.g., excessive concern about health)

• Delirium

• Excessive daytime sleepiness and sudden episodes of falling asleep

• Amnesia (memory impairment)

• Hyperkinesia (increased movements and inability to remain still)

• Weight gain

• Allergic reactions (e.g., skin rash, itching, hypersensitivity)

• Fainting

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*

• Inappropriate secretion of antidiuretic hormone*

• Restlessness

• Dyspnea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:

• Strong urge to gamble excessively despite serious personal or family consequences.*

• Altered or increased sexual interest and behavior concerning to you or others, for example, increased libido.*

• Compulsive buying or spending.*

• Binge eating (consuming large amounts of food in a short period of time) or

• compulsive eating (eating more food than normal and more than needed to satisfy hunger)*

• Delirium (reduced level of consciousness, confusion, loss of contact with reality)

Rare (may affect up to 1 in 1,000 people)

• Mania (agitation, feeling elated or overexcited)

Frequency not known (cannot be estimated from available data):

• After stopping or reducing treatment with pramipexole: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as dopamine agonist withdrawal syndrome or DAWDS).

Inform your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

For adverse effects marked with *, a precise frequency estimate is not available, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

If you have Restless Legs Syndrome, you may experience the following adverse effects:

Very common (may affect more than 1 in 10 people)

• Nausea
• Symptoms starting earlier than usual, becoming more intense, or affecting other limbs (worsening of restless legs syndrome)

Common (may affect up to 1 in 10 people)

• Changes in sleep pattern, such as insomnia and somnolence
• Tiredness (fatigue)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling sick)

Uncommon (may affect up to 1 in 100 people)

• Urge to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inappropriate secretion of antidiuretic hormone*
• Dyskinesia (e.g., abnormal involuntary movements of limbs)
• Hyperkinesia (increased movements and inability to remain still)
• Paranoia (e.g., excessive concern about health)
• Delirium
• Amnesia (memory impairment)
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Excessive daytime sleepiness and sudden episodes of falling asleep
• Weight gain
• Hypotension (low blood pressure)
• Fluid retention, usually in the legs (peripheral edema)
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual disturbance
• Weight loss including loss of appetite
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)*
• Inability to resist the impulse, desire, or temptation to perform an action that could be harmful to you or others, which may include:
• Strong urge to gamble despite serious personal or family consequences.
• Altered or increased sexual interest and behavior that may concern you or others, for example, increased libido.*
• Compulsive buying or spending.*
• Binge eating (large amounts of food in a short period of time) or compulsive eating (more food than normal and more than needed to satisfy hunger)*
• Mania (agitation, feeling elated or overexcited)*
• Delirium (reduced level of consciousness, confusion, loss of contact with reality)*

Frequency not known (cannot be estimated from available data):

• After stopping or reducing treatment with pramipexole: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as dopamine agonist withdrawal syndrome or DAWDS).

Inform your doctor if you experience any of these behaviors; they will advise you on ways to control or reduce the symptoms.

For adverse effects marked with *, a precise frequency estimate is not available, as these adverse effects were not observed in clinical trials involving 1,395 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexole Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexol Stada

The active substance is pramipexole.

Each Pramipexol Stada tablet contains 0.18 mg of pramipexole (as pramipexole dihydrochloride monohydrate).

The other components are:

Betadex

Maize starch

Povidone K 30

Microcrystalline cellulose

Colloidal anhydrous silica

Magnesium stearate

Appearance of the product and contents of the pack

White to off-white, oval, biconvex tablet, scored on both sides. The tablet can be divided into equal halves.

Pramipexol Stada 0.18 mg tablets are supplied in 10-tablet blister strips, in boxes containing 3, 6, 10 or 2 x 10 blister strips (30, 60, 100 or 2 x 100 (200) tablets).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastraße 2 – 18

D-61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel,

Co. Tipperary

Ireland

or

LAMP SANPROSPERO S.p.A

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

This medicinal product has been authorised in the Member States of the EEA under the following names:

BE: Pramipexole EG 0.18 mg tablets

DE: Pramipexol Stada 0.18 mg Tablets

DK: Pramipexol Stada 0.18 mg tablets

FI: Pramipexol Stada 0.18 mg tablet

FR: PRAMIPEXOLE EG 0.18 mg comprimé

HU: Pramipexol Stada 0.18 mg tablet

IE: Miramel 0.18 mg tablets

IT: Pramipexolo EG 0.18 mg compresse

LU: Pramipexole EG 0.18 mg comprimés

PL: Pramipexol Stada 0.18 mg tablets

RO: Pramipexol Stada 0.18 mg comprimate

SK: Pramipexol Stada 0.18 mg tablets

ES: Pramipexol Stada 0.18 mg tablets EFG

SE: Pramipexol Stada 0.18 mg tablets

Date of the most recent revision of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es